[Federal Register: January 27, 2004 (Volume 69, Number 17)]
[Notices]
[Page 3922-3923]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ja04-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0425]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Event Pilot Program for Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information
including each proposed extension of an existing information
collection, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting requirements related
to the adverse event pilot program for medical devices.
DATES: Submit written or electronic comments on the collection of
information byMarch 29, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
[[Page 3923]]
Adverse Event Pilot Program for Medical Devices--(OMB Control Number
0910-0471--Extension)
FDA is requesting approval from OMB for clearance to continue to
conduct a pilot project to evaluate aspects of a national reporting
system mandated by the Food and Drug Modernization Act (FDAMA) of 1997.
Under section 519(b) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360(i)(b)), FDA is authorized to require manufacturers
to report medical device related deaths, serious injuries, and
malfunctions; user facilities (hospitals, nursing homes, ambulatory
surgical facilities and outpatient diagnostic and treatment facilities)
to report device-related deaths directly to FDA and to manufacturers,
and to report serious injuries to the manufacturer. Section 213 of
FDAMA amended section 519(b) of the Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360i(b)). This amendment legislated the replacement of
a universal user facility reporting by a system that is limited to a
``* * * subject of user facilities that constitutes a representative
profile of user reports'' for device related deaths and serious
injuries. This amendment is reflected in section 519(b)(5)(A) of the
act.
FDA is the regulatory agency responsible for the safety and
effectiveness of medical products including medical devices and
radiological products. Important questions about medical devices, such
as those concerning user experience, durability, and rare effects may
not be answered until after the device has been marketed. To protect
the public health, FDA must be able to rapidly collect information
pertaining to adverse events associated with medical devices after they
have been marketed. This system is called the Medical Product
Surveillance Network (MedSun). The current universal reporting system
remains in place during the pilot stages of the new program, and until
FDA implements the new national system by regulation. This legislation
provides FDA with the opportunity to design and implement a national
surveillance network, composed of well-trained clinical facilities, to
provide high quality data on medical devices in clinical use.
Before writing a regulation to implement the large-scale national
MedSun reporting system, FDA has been conducting a pilot project to
ensure all aspects of the new system address the needs of both the
reporting facilities and FDA. This pilot project began with a small
sample (approximately 25) and was planned to increase to a larger
sample of approximately 250 facilities over a period of approximately 3
years. Data collection began in February 2002 and has been increasing
since that time. FDA has achieved its recruitment goals each year,
reaching 180 sites at the end of fiscal year (FY) 2003. FDA will reach
a total of 240 for FY 2004 and will reach the final goal of 250 by FY
2005. The program has proven to be very popular with sites as FDA has
gained a national reputation, with hospitals waiting in line to join.
However, FDA's current resources will not permit FDA to expand beyond
250 sites at this time.
The pilot originally had 3 parts to the data collection: (1)
Collecting demographic profile information about the participation
facilities, (2) implementing an electronic version of the portions of
the MedWatch form (FDA Form No. 3500A, OMB control number 0910-0291)
used to report adverse events occurring with medical devices, and (3)
adding additional voluntary questions to the data collection. To date,
these 3 features remain unchanged. However, there has been an addition
to the data collection that was approved by OMB in the spring of 2004.
Therefore, the fourth part of the collection system is the Medical
Device Engineering Network (M-DEN)--a place on the MedSun software for
the reporters to share information with each other.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
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Number of Annual Frequency Total Annual
Data Type Respondents per Response Responses Hours per Response Total Hours
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MedSun 250 8 2,000 .75 1,500
M-DEN 83 10 830 .50 415
Total .................. .................. .................. .................. 1,915
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Currently, FDA has 180 sites participating in MedSun pilot program,
but expects to have 250 sites over the next 2 years. The frequency of
response reflects what FDA has actually been receiving as the average
number of submissions in the MedSun Program. While 6 is the actual
average for submissions, FDA hopes to increase this number to 8 once
their educational materials reach potential respondents. The time
estimated to respond is based on feedback FDA has received from current
MedSun reporters.
At this time, FDA estimates that 1/3 of the total number of
respondents will access M-DEN aspect of the MedSun software, or
approximately 83 persons per year. Each respondent is expected to post
5 problems and respond to 5 problems posted by other MedSun
participants for a total of 10 responses per year. It is expected that
each visit to the bulletin will not take longer than 30 minutes.
Dated: January 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1587 Filed 1-26-04; 8:45 am]
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